RF-25.16.3 - Web viewHave you remembered to include everything? Completed application form (Word format, .doc or .docx) & signed application form (Word .doc or .docx or .Pdf)

IVD RecertificationApplication & Review Form

Please tick all that apply: 3 Year RENEWAL Fast Track (expedited)

Directive(s) that apply:Directive NSAI File Number

IVDD (98/79/EC) 304. /

Instructions:1. Please complete all relevant sections of the form (excluding the

NSAI Review sections). If the data is in supporting documentation, please ensure that there is a clear reference to the exact location of this information.

2. Please submit an unsigned version of this Application in Word as well as a signed copy - either scanned/secured (pdf) copy.

3. All application forms and supporting data to be forwarded in soft copy via one of the following (Hard copies not required)

a. NSAI upload facility: see http://www.nsaiinc.com/b. CDc. Memory Stick

Europe N. AmericaNSAI1 Swift Square,Northwood,Santry, Dublin 9IrelandPhone : (01) 807 3929Fax : (01) 807 [email protected]

NSAI Inc.402 Amherst StreetNashuaNH 03063USAPhone : (603) 882 4412Fax : (603) 882 [email protected]

GRF-25-32 Rev 1.1 Page 1 of 20

CHECKLIST

Have you remembered to include everything?Completed application form (Word format, .doc or .docx) & signed application form (Word .doc or .docx or .Pdf)Summary of all substantial changes implemented during the current product certification cycleIdentification of relevant Harmonized Standards amended duringthe product certification cycle, and proof of compliance with the amended standard(s) Performance / Complaint AnalysisRisk Management Plan / Most recent risk assessment document*Sterilization Revalidation(s) – Validation protocol and most recent validation resultsUpdated Performance Evaluation Study & associated supporting

data


DECLARATION(s) BY APPLICANTIn making this application we declare: The information in this form is correct We have not lodged an application with any other notified body to undertake

conformance assessment procedures for the same product(s) / device-related quality system mentioned.

We undertake to institute and keep up to date a systematic procedure to review experience gained from devices in the post-production phase and to implement appropriate means to apply any necessary corrective actions and notifications, taking account of the nature and risks in relation to this product.

We agree to inform/notify the Competent Authorities and NSAI of the following

- any event which meets all three basic reporting criteria (A-C) listed in the CRITERIA FOR INCIDENTs TO BE REPORTED BY MANUFACTURERS TO COMPETENT AUTHORITIES in the current MEDDEV 2 12-1 (current revision) which is considered an INCIDENT. Where an event has or could result in INDIRECT HARM (as defined in MEDDEV 2 12-1 (current revision) and that led or might have led to death or serious deterioration in state of health, we should submit a Manufacturer’s INCIDENT Report (in accordance withMEDDEV 2 12-1 (current revision).

-Any action taken to reduce a risk of death or serious deterioration in the state of health associated with the use of a MEDICAL DEVICE that is already placed on the market should be reported through a Field Safety Corrective Action Report (as defined in MEDDEV 2 12-1 (current revision). Such actions, whether associated with direct or indirect harm, should be reported.

- Whilst it may be difficult to determine if a serious deterioration in the state of a patient’s health was or could be the consequence of an erroneous result obtained with an IVD or a diagnostic device, or the consequence of an error by the USER or third party. In cases of doubt a report should be submitted (See MEDDEV 2 12-1 (current revision)).

- In the case of potential errors by USERs or third parties, labelling and instructions for use should be carefully reviewed for any possible inadequacy. This is particularly true for devices used for self-testing where a medical decision may be made by the patient. Inadequacies in the information supplied by the MANUFACTURER that led or could have led to HARM to USERs, patients or third parties should be reported.

In particular, it can be extremely difficult to judge events in which no HARM was caused, but where HARM could result if the event was to occur again elsewhere.

We agree to pay all applicable fees and understand that non-payment of fees will result in withdrawal of approval.

We undertake to fulfill the obligations imposed by the quality system approved We undertake to keep the approved quality system adequate and effective. We agree to inform NSAI of any plan for substantial changes to the quality system

or the product-range covered. We shall inform NSAI which issued the EC design-examination certificate of any

changes to the approved design, wherever the changes could affect conformity with the essential requirements of the Directive or with the conditions prescribed for the use of the device.


We authorize NSAI to carry out all the necessary inspections and supply it with all relevant information, in particular:

- The documentation on the quality system- The data stipulated in the part of the quality system relating to design,

such as the results of analyses, calculations, tests etc., (where relevant)- The data stipulated in the part of the quality system relating to

manufacture such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.

On receipt of the CE Mark re-approval from NSAI, it is our intention to commercialize the product. In the event of non-commercialize of the said product we commit to notify NSAI of this decision.

We authorize and agree to allow NSAI access to all critical subcontractors and crucial suppliers, and all sites where the device or it’s crucial components are produced.

We agree to allow NSAI access to the Legal Manufacturer’s premises, and /or any of the above listed sites at any time for the purposes of performing unannounced audits.

As necessary we agree to provide all necessary support in acquiring the necessary travel papers, including VISA, to facilitate NSAI access to the above listed locations.

We agree to inform NSAI of the periods when the devices identified in this application will not be manufactured.

We understand that NSAI may end this contract with the Legal Manufacturer if permanent unannounced access to the above listed sites is no longer assured.

We understand that NSAI may cancel any unannounced audit at any time if the safety and security of NSAI personnel cannot be assured.

Signed on behalf of the Manufacturer:

Date:

Name (please print):Position / Title:Contact person (if different to Manufacturer):e-mail: Phone:


Section 1 - Manufacturer and Product DetailsMANUFACTUER - Please complete the following table

Table 1 – Manufacturers Information(Legal) Manufacturer’s Name (Legal) Manufacturer’s Address Design Site(s): Manufacturing Site(s):(i.e. sites of actual manufacture)

Assembly Site(s) if applicable Sterilization Site(s) if applicable Scope of Site(s):(i.e. as shown on the QMS cert)

Name and address of EU Authorized Representative(if applicable)

Product/Product Family Name:(In compliance with NB/MED/2.5.1/REC4 & NBOG’S Best Practice Guide 2006-2)

GMDN Reference Number: See www.gmdnagency.com/IVD Type Annex II List B Self-Test IVDs not covered by Annex II Conformity Assessment RouteDate of this application (i.e. date of Declaration of Applicant)

NSAI REVIEWNSAI registration(s):Product: # QMS: # Client QMS Certificates are valid and scope of registration(s) remains adequate for product family under reviewProduct family name in line with GMDNVerify that the conformity assessment selected is appropriate for the type of

IVDDIs the scope of the QMS in line with the Annex Chosen (e.g. design)

Are additional certificates required (e.g. EC type certs)

Has any information above changed during the current product certification cycle (if so, review & confirm that substantial change notification was previously received and reviewed by NSAI – see Section 3)


Technical Reviewer: Date: COMMENTS:

Clinical Reviewer (if applicable): Date: COMMENTS:

Additional Reviewer (if applicable): Date: COMMENTS:

QUERIES: No Yes Number(s):

Section 2 - Intended Use of the Device / Labeling and IFU

Please enter a full description of the intended use of the device, and identify contraindications.

Also provide copies of current product labels and Instructions for Use (IFU’s)

Full Description of Intended Use:

Has any of the following been revised or amended during the current product certification cycle? (see Section 3 and provide change details there)

Table 2: Intended Use/Labeling/IFUDetail Yes/No Reference the amendment

number submitted to NSAIIntended useIndications for UsePatient populationWarnings and precautionsProcedureQuality ControlResultsCalibration detailsLimitation of the procedureExpected valuesSpecific performance characteristicsContraindications

NSAI REVIEWIntended Use clearly stated Yes NoDo the “intended use” and “contraindication” statements above match information found in product labeling and Instructions for Use? Yes No


Legal Manufacturer and EU Rep. Information included on labeling? Yes No

Does that information match Table 1 above. Yes NoAre correct symbols utilized? Yes No N/A





Section 3 – Review of ChangesPart 1: Substantial changes

Table 3: List of substantial changesPlease provide a complete listing of all substantial changes made during the current product certification cycle.

Product(s) affected & Amendment #

Description of Change

Part 2: Changes to the Technical Documentation: Has there been any changes to the technical documentation that apply to the criteria that are listed in Table 4

Yes No

If “Yes” Please list the titles below and provide the data to NSAI;

Table 4: List of Technical changesChanges to: Yes No N/A Briefly Describe Report GRF-25-32 Rev 1.1 Page 7 of 20

NumberBuffersElectrolytes (Na+, Ca++, etc.)Proteins/Enzymes (e.g., Recombinant, Activity, Affinity, Purity, etc.)Additives/Stabilizers (e.g., glycerol, 2-mercaptoethanol, etc.)Reference Standards (medicinal agent, antibody, protein, etc.)Accessories to IVDs (e.g., pre-processing of biological samples, etc.)Packaging (vials, etc.)SoftwareInstruments/HardwareOperating SystemsSubcontractors/SuppliersOthers





Section 4 - Product Stability & On-Going Testing

Using Table 5 below, please specify the current shelf-life of the product:

If additional Tables are required, please copy and paste this format underneath Table 5


Table 5 Stability claimsProduct nameModel NumbersShelf life Time Period and storage conditions (where applicable, if

not please state N/A)Claimed Shelf life

In use stability

On board stabilityRe-constitution

Open vial/bottle

Shipping/Transport StabilityDuration of transportExpected temperaturesHumidity

Has the product shelf life / expiry date changed during the current product certification cycle? Yes No If yes, please explain:

Is the stated shelf life based on accelerated or real time aging Yes No

Please provide an update on any real time aging activities currently underway, or completed during the current product certification cycle: N/A Yes No

Is regular monitoring of the stability of an IVD reagent already on the market completed? Yes No

If Yes, please explain and provide data: If No , please provide a rationale

NSAI REVIEWAll Devices:

Does stated shelf life above match previously approved submission or amendment?

Does the stated shelf life above match the labels/IFU?






Section 5 - Harmonized StandardsPlease indicate if any relevant Harmonized Standards have been amended during the current product certification cycle.Please provide objective evidence of compliance with any revised standards noted below.

In Table 2 below, please list any updated Harmonized Standards and address how the revised standard has been considered and implemented

In the cases where there have been changes or updates to the technical content/requirement of the standard, please provide evidence of compliance to the new standard.

For seehttp://ec.europa.eu/enterprise/policies/european-standards/documents/harmonised-standards-legislation/list-references/medical-devices/index_en.htm

Harmonized Standard Year ComplianceYes/No

Evidence of Compliance

EN 61010-2-101 2002 Yes Report # x, pg x, para. XEN 61326-2-6 2006 Yes Report # x, pg x, para. XEN 62304 2006 Yes Report # x, pg x, para. XEN 62366 2008 Yes Report # x, pg x, para. X

Table 2: Compliance with updated Harmonized StandardsHarmonized Standard Year Compliance

Yes/NoEvidence of Compliance

GRF-25-32 Rev 1.1 Page 10 of 20





Section 6 – Complaint Summary / Vigilance Reports / Trend Analysis

Please provide a summary analysis of product complaints and Vigilance Reportable Incidents as outlined below

A. COMPLAINTS:1. Is the device commercialized Yes No

If “No” please explain -

2. Time period of the complaint data being provided – Last 3yrs – Lifetime of the device

3. TOTAL UNIT SALES TOTAL No. COMPLAINTS TOTAL No. of REPORTABLE EVENTS (worldwide)

4. Please provide an analysis of complaint data over the stated period of time, in either graphic or table form, summarizing types of complaints, (e.g. performance related, clinical user related, labeling issue, off-label use, product misuse, complaint justified / non-justified) with quantity and % total sales

5. Please provide data on up-to-date QC / Production trends

B. VIGILANCE REPORTS:Summary of all Vigilance Report(s) submitted to EU Competent Authorities during the current product certification cycle. Has this product been the subject of product recalls or Incident Reports in other Regulatory geographies outside EU? If yes, please summarize and provide details

C. CORRECTIVE ACTIONS:

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In the table below, please provide a summary of corrective actions implemented as a result of vigilance or complaint trends.

Vigilance/complaint number

Corrective action number

Description of corrective action

Corrective action Status

NSAI REVIEWSuitable rationale if device not commercialized at 3yr renewalComplaint data & possible trends reviewedVigilance reports & possible trends reviewedPerformance issues worldwide considered & reviewedReview data on up-to-date QC / Production trends





Section 7 – Risk Management / Risk Analysis Please provide the current Risk Management Plan/ Report and most recently completed Risk Analysis, including a signed and dated conclusion regarding residual/remaining risks. Has EN 14971 Annex H (Guidance on Risk Management of in vitro diagnostic medical devices been considered)

NOTES- Additional information may be required for devices containing tissue of animal origin, or human blood derivatives- If applicable please ensure to include relevant risk analysis for IVD Medical Equipment, Software

GRF-25-32 Rev 1.1 Page 12 of 20

NSAI REVIEWCompliance with ISO 14971 – version: Has Annex H (Guidance on management for in vitro diagnostic medical

devices) been considered?Residual/remaining risks acceptable, based upon type of device, special circumstances (e.g. drug/device, animal tissue, human blood), and intended application of the deviceSuitable cross-functional team involved in risk assessmentClinical/Performance risks identified by suitably qualified person (actual

clinical risks involved in the use, application to the treatment of the clinical condition) Signed and dated risk-to- benefit conclusion by a qualified individual regarding residual/remaining risksRisk analysis comprehensive and adequateOn-going Risk Management Plan suitableSolutions adopted by Manufacturer conform to safety principles, taking account of the generally accepted state of the art

NSAI REVIEWTechnical Reviewer: Date: COMMENTS:




Section 8 – Sterilization1. Is product provided Sterile? Yes No

If no, please continue to Section 9

Please provide the Sterilization Validation / Revalidation protocol(s) & most recently completed Sterilization Cycle Revalidation Report(s) and populate Table 3 below

Table 3– Sterilization Information SummaryDevice sub-family

Cat. Number

Sterilization Method

Sterilization Location

Protocol/ Report No.

Site resp for Release

GRF-25-32 Rev 1.1 Page 13 of 20

2. If EtO is utilized for Sterilization, please categorize the device according to the duration of contact below, and provide data in support of the most recently completed residual testing:

A – Limited Exposure B – Prolonged Exposure C – Permanent Contact

NSAI REVIEWCompliance with relevant harmonized standard for sterilization - If harmonized standard for sterilization is not followed, identify the industrystandard used for cycle determination & validations (e.g. AAMI, TIR)EtO Residuals compliant with EN ISO 10993-7 – version Validation / Revalidation schedules defined, documented and maintained

Validation Report reviewed & results support a validated sterilization cycle.

NSAI REVIEWTechnical Reviewer: Date: COMMENTS:



Section 9 – Clinical Performance UpdateFor the manufacturer:

1. Provide an updated performance evaluation report that is signed and dated by a relevant clinical expert(s) in compliance with EN 13612 (current revision) and Commission Recommendation (2013/473/EU) point 6

2. Provide a copy of the CV/resume of the relevant clinical expert(s) responsible for the updated performance evaluation

The report should contain adequate updated performance evaluation data in support of the performances claimed and further supported by a reference measurement system (when available), including detailed information on:

the reference methods, the reference materials, the known reference values, and

GRF-25-32 Rev 1.1 Page 14 of 20

the accuracy and units of measurement used.

This data should arise from studies in a clinical or other appropriate environment or result from relevant biographical references.

Other key aspects of such an evaluation include:

-Performance history over the past 3 years-Any changes made to the device;-Risk Reports including the risk/benefit analysis; and, -Post market experience and review of the current state of the art (e.g., clinical/scientific literature reviews, review of regulatory databases, etc.).

NSAI REVIEW

TO BE COMPLETED BY NSAI CLINICAL REVIEWER ONLY

NSAI Performance Review

Evaluation is in accordance EN 13612:2002 (Performance evaluation of IVD MDs) for all other devices.

Has adequate performance evaluation data been supplied showing the performances claimed by the Manufacturer & supported by a reference measurement system (when available)?

Review details of the post market clinical follow-up.

Evidence of the competence and relevancy of the clinical evaluator provided.

Chronology of ReviewStarted on by

SCIENTIFIC VALIDITY OF ANALYTE DEVICE DESCRIPTION INTENDED USE

GRF-25-32 Rev 1.1 Page 15 of 20

IVD CLASSIFICATION

LABELLING & IFU

ERs/HARMONISED STDS

PERFORMANCE/COMPLAINT ANALYSIS

RISK ASSESSMENT

POST MARKET EXPERIENCE

NOTE: IF SIGNIFICANT ENTRIES ARE MADE IN SECTION 3 OF THIS APPLICATION, THE FOLLOWING PARAMETERS MAY NEED TO BE RE-EVALUATED AS PART OF THE 3 YEAR REVIEW:

ANALYTICAL PERFORMANCE (e.g, analytical sensitivity/specificity, etc.)

CLINICAL PERFORMANCE (e.g., diagnostic sensitivity/specificity)

CLINICAL UTILITY (NOTE: Not formally required)

NSAI Clinical Assessment: (Chronology of review)

Date:

Conclusion:

Internal & External Assessors:

Signature: Date:

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Section 10 – Additional InformationPlease use this section to document any additional information not already covered above.

Section 11 – NSAI QueriesNSAI Query #1 –

Company ResponseGRF-25-32 Rev 1.1 Page 17 of 20

Response Disposition:

NSAI Query #2 –

Company Response


NSAI Query #3 –

Company Response


NSAI Query #4 –

Company Response


NSAI Query #5 –

Company Response


Query Summary / Disposition:

Query Disposition By Date1.2.3.4.5.

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GRF-25-32 Rev 1.1 Page 19 of 20

Section 12 - Conclusion of Assessment

NOTIFIED BODY STATEMENT:Conclusion –

Intended use: Shelf life (if applicable): Approval conditions:

ROLE Name DateFile ManagerExpert OpinionBiomechanical ReviewElectrical ReviewClinical Review

Remarks: By signing this technical review report, the reviewer confirms that that he/she has no conflict of interest with the above named company e.g. training, consultancy, financial, personal or political) that would affect the integrity of the technical review process and hence the review results

ApprovalPRESENTED TO THE TECHNICAL REVIEW COMMITTEE MEETING ON:

Outcome of Meeting: Follow Up required: No YesIf “Yes” please provide details –

APPROVAL DEMONSTRATED by SIGNING APPROVAL AMENDMENT RECORD

GRF-25-32 Rev 1.1 Page 20 of 20

Documents

RF-25.16.3 - Web viewHave you remembered to include everything? Completed application form (Word format, .doc or .docx) & signed application form (Word .doc or .docx or .Pdf)